SPL v1
SPL
SPL Set ID 11d6315b-8936-7346-e063-6294a90a31b0
Route
TOPICAL
Published
Effective Date 2024-02-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Oxide (0.25 g)
Inactive Ingredients
Alpha-tocopherol Acetate Shea Butter Coconut Oil Sunflower Seed Oil Glycereth-8 Esters Olive Oil Peg-8 Beeswax Rosa Canina Fruit Oil Argania Spinosa Seed Avocado Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-20

Description

Zinc Oxide (25%)


Medication Information

Warnings and Precautions

Warnings: •For external use only. •Do not use on

damaged or broken skin. •When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. •Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Indications and Usage

Uses: •Helps prevent sunburn • If used as directed with

other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging

caused by the sun

Dosage and Administration

Directions: Apply liberally 15 minutes before sun

exposure

• Reapply: After 80 minutes of swimming or sweating

• Immediately after towel drying At least every 2 hours.

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10am-2pm. • Wear long sleeve shirts, pants, hats and sunglasses.

• For children under 6 months: consult a physician.

Description

Zinc Oxide (25%)

Section 44425-7

Other information: Protect this product from excessive heat and direct sun.

Section 50565-1

•Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6

Inactive Ingredients: Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Tocopheryl Acetate.

Section 51945-4

Section 55105-1

Sunscreen

Section 55106-9

Zinc Oxide (25%)


Structured Label Content

Indications and Usage (34067-9)

Uses: •Helps prevent sunburn • If used as directed with

other sun protection measures (see Directions),

decreases the risk of skin cancer and early skin aging

caused by the sun

Dosage and Administration (34068-7)

Directions: Apply liberally 15 minutes before sun

exposure

• Reapply: After 80 minutes of swimming or sweating

• Immediately after towel drying At least every 2 hours.

• Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10am-2pm. • Wear long sleeve shirts, pants, hats and sunglasses.

• For children under 6 months: consult a physician.

Warnings and Precautions (34071-1)

Warnings: •For external use only. •Do not use on

damaged or broken skin. •When using this product, keep out of eyes. Rinse with water to remove. Stop use and ask a doctor if rash or irritation occurs. •Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 44425-7 (44425-7)

Other information: Protect this product from excessive heat and direct sun.

Section 50565-1 (50565-1)

•Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center immediately.

Section 51727-6 (51727-6)

Inactive Ingredients: Helianthus Annuus (Sunflower) Seed Oil, Cocos Nucifera (Coconut) Oil, Olea Europaea (Olive) Fruit Oil, Beeswax, Butyrospermum Parkii (Shea Butter), Persea Gratissima (Avocado) Oil, Argania Spinosa Kernel Oil, Rosa Canina Fruit Oil, Tocopheryl Acetate.

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Sunscreen

Section 55106-9 (55106-9)

Zinc Oxide (25%)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)